26 July 2023 - The agenda for the November 2023 PBAC meeting is now available.

For the time being, there are 36 agenda items; all appear to be submissions from the pharmaceutical industry. The agenda will no doubt be revised over time with the addition of some medicines rejected or deferred by the PBAC earlier this month.

The 36 submissions are for:

• 34 medicines
• 0 gene therapies
• 0 medicinal preparations
• 2 vaccines

As we read it, the agenda is for:

• 9 new medicines
• 0 new vaccines
• 1 new gene therapy
• 2 new biosimilar medicines
• 16 new indications
• 0 new combination products
• 1 restriction change
• 2 new strengths
• 4 new formulation
• 1 therapeutic relativity
• 0 reviews
• 1 price review

As usual, the agenda is dominated by medicines for just a few therapeutic areas:

• Oncology (11 submissions)
• Immunology (4 submissions)
  
• Infectious disease (4 submissions)

AstraZeneca is the leading applicant with four submissions. Pfizer lodged three submissions and GSK & Orion lodged two submissions. Two usual suspects (Janssen and Novartis) did not lodge a submission.

We estimate the following submissions have been lodged under the TGA-PBAC parallel processes insofar as they have not yet been approved by the TGA. This may not be 100% correct given the limited level of detail that is currently in the public domain.

• Cemiplimab (non-small-cell lung cancer)
• Empagliflozin (Jardiance) (renal failure)
• Ivacaftor (cystic fibrosis)
• Olaparib (prostate cancer)
• Pneumococcal polysaccharide conjugate vaccine 20 valent, adsorbed) (vaccination)
• Secukinumab (hidradenitis suppurativa)
• Tislelizumab (non-small-cell lung cancer)
• Trastuzumab deruxtecan (breast cancer)

Some insights:

• Novo Nordisk has lodged a resubmission for semaglutide (Wegovy) for obesity.  The target patient population is patients with "severe obesity despite prior participation in an appropriate lifestyle-based weight management intervention"
• The PBAC will consider three submissions for medicines for patients with breast cancer (abemaciclib, olaparib and trastuzumab deruxtecan); two are for patients with early breast cancer
• The PBAC will consider three submissions for medicines for patients with non-small-cell lung cancer (cemiplimab, osimertinib mesylate and tislelizumab); one is for patients with early disease, the other two are for the first-line treatment of patients with advanced/metastatic disease

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